Saeed Yousef
Product development Person In charge
Sharjah,Sharjah
Summary
With over 15 years of experience in the pharmaceuticals industry, I have expertise in PDL, Regulatory Affairs, Production, and Quality Control. Strong leadership skills enable effective communication with individuals at all levels of the organization. Proven track record of collaborative teamwork to achieve goals. Analytical skills are exceptional. Dedicated to maintaining high quality standards. Seeking opportunity to contribute value to respected organization. Academic background and interpersonal skills ensure confidence in further growth and significant impact in the field of Pharmaceuticals.
Overview
19
19
years of professional experience
5
5
years of post-secondary education
Work History
Product Development Person In Charge (Formulation, Packaging and Analytical Development)
Medpharma, Bausch Health Pharmaceuticals
Sharjah
9 2022 - Current
- Screen new products to be developed and perform pre-formulation studies.
- Review and approve master processing instructions and manufacturing batch record.
- Lead manufacturing of validation batches and troubleshooting of production batches
- Manage training program for new PDL personnel.
- Provide CMC oversight and regulatory interface with Health authorities, in strong collaboration with Regulatory Affairs teams
- Review (including conducting regulatory impact assessments), coordinate and prepare CMC documentation for CTD modules of submissions, registration and lifecycle management variations
- Lead as required project Launch Meetings, Review Meetings and Project Team meetings
- Enforce projects completion of artworks scientific data (English and Arabic)
- Lead creation, review, approval and implementation of labeling data including patient information leaflet (PIL) in English and Arabic languages as per guideline for different countries
- Supports Cross Functional Labeling Team for various labeling projects for labeling effectively, and independently
- Enforce regulatory intelligence, identify regulatory updates pertaining to product development, PDL SOPs and work instructions
- Review and approve PDL SOPs and working instructions, delegate tasks as needed to PDL team to perform procedural gap assessment to fulfill required tasks.
- Collaborate with stakeholders for supplier and vendor qualification process.
- Lead, in collaboration with quality team, qualifies CRO as per local legislation. Manage BE protocol creation, review, and support final approval in collaboration with medical, PV, and upper management.
- Manage change control requests for deviations, planned deviations, or non-conformance identified for processes.
- Manage any related CAPA creation, completion, closure.
- Ensure effective measures for corrective and preventive action taken.
- Qualifying new raw materials (Active and Excipients) as part of supplier qualification.
- Identify suitable raw materials to be used in composition formulas based on QbD trials and determination of raw materials' critical martial attributes.
Product Development Specialist (Formulation, Packaging and Analytical Development)
Medpharma, Bausch Health Pharmaceuticals
03.2011 - 09.2022
- Produce pilot batches of all dosage forms (Solid, semi-solid, Capsule, Syrup, suspension, Medical Aesthetic, Cosmetics products, and powder for oral suspension) and external preparation in consultation with PDL team.
- Observe trial batches to record any changes, and document results obtained from these batches.
- Preparation of stability study protocol, product development report, and compatibility studies.
- Support manufacturing of validation batches and troubleshooting of production batches.
- Prepare and follow up on Chemistry, Manufacturing, and Controls files, as well as work closely with multiple stakeholders such as scientific, technical, quality, and commercial departments.
- Authorize and review PDL SOPs and working instructions, perform procedural gap assessment to fulfill required tasks.
- Participate in product development team for early development of product to provide labeling leadership in developing target labeling concept to guide design and analysis plan.
- Support change control requests for deviations, planned deviations, or non-conformance identified for processes. Support any related CAPA creation and closure.
- Monitor worldwide regulation changes pertaining to labeling regulations and maintain labeling SOP and work instructions.
- Support Regulatory Affairs to ensure and re-check submitted product registration documents will fully meet local regulatory requirements.
- Prepared detailed functional specification documents for product innovation and improvements.
- Collaborated with Research and Development, Marketing and supply chain teams from development to product launch to achieve milestone deadlines.
- Collaborated with suppliers to obtain new raw materials and improve supply chain for smooth production.
- Organized trade shows and product demonstrations to showcase new offerings, generating interest from potential clients and increasing market awareness.
- Mentored junior team members in industry best practices, enhancing their skills as Product Development Specialists.
Visiting Lecturer
Dubai Pharmacy College
01.2017 - 12.2018
- Visiting Lecturer for GCC Labeling and packaging guidelines for Pharmaceuticals company.
R&D formulator
Medizen Pharmaceutical Industries
04.2008 - 02.2011
- To ensure that, the new pharmaceutical products are properly selected and well developed.
- Improvement of already formulated products takes place when dictated.
- The product samples for registration purposes are prepared according to the product design.
- The manufacturing formula and processing instructions are well-prepared and revised.
- The packaging instructions are suitable for each pharmaceutical product.
- The technology transfer reports are clear and legible.
- Scaling up to production sections is successful.
- The 1st, three successive production batches (Validation batches) of different pharmaceutical products, prepared with production personnel, are successful.
- Provisional batch production records are well-prepared and revised.
- Troubleshooting in production, if any, is handled effectively.
- Comparing different formulations, for the same pharmaceutical product, during the pharmaceutical product's development and upon storage, is performed to choose the proper formulation for each pharmaceutical product.
- Documented activities are conducted in a GMP-compliant and regulatory-accepted manner.
- Cooperate with the Procurement Department in choosing starting materials effectively.
- For fabrication and development of cosmetics formulation.
- Design composition formula for sterile products (solution) and use the formulas by technology transfer to other toll manufacturing companies.
Analyst in raw material lab
MEDIZEN Pharmaceutical Industries
11.2007 - 04.2008
- Performing all physical and chemical analysis for raw and packaging material according to predefined specifications.
- Analysis of starting material samples (validation sample, cleaning validation sample, planning sample, and water sample) and validation of water.
- Preparation and standardization of chemical reagent.
- Proper operation and maintenance of instruments.
- Receiving, labeling, and arranging lab.
- Chemicals and official standards.
- Work on different instrumental UV unit, Karl Fischer, HPLC, IR unit.
- GC unit, atomic absorption.
R&D formulator
EASY BEAUTY Cosmetics Industries
07.2005 - 11.2007
- Analyzed the company procurement process based on historical data and questionnaire results, which led to the identification of the weak points in the system.
- Found in the start team of the company.
- Develop the formulation of cosmetics products and wet wipes with different types of baby wet wipes with cream.
- Refresh wet wipes and design a new formulation of antibacterial makeup removal wet wipes.
- Developed formulations (Baby cream, Deodorant cream, Aloe Vera facial cleansing gel, Hair removal cream, Tonic solution, and make-up removal, and other formulations).
Education
Master of Science - Biotechnology
Alexandria University
Egypt 11.2006 - 05.2008
Bachelor of Science -
AL-AZHAR, University
Egypt 10.2001 - 05.2005
Skills
Preparing Quality Risk Management report for the new/existing products
Team Management
Problem-Solving
Computer Skills
Friendly, Positive Attitude
Microsoft word, Excel, Power Point, Adobe photoshop and Adobe illustrator
Co-Ordination with Cross-Functional Teams
Labeling and Packaging development
Certified as internal auditor
Preparing Quality Risk Management report for the new/existing products
Accomplishments
- Awarded as Professional Excellence Award 2015 for major contributions above & beyond normal job requirements.
- Awarded as Quality recognition Award 2019 for above & beyond contributions and commitment to achieve highest quality standard.
Soft Skills
Fluent in Arabic and English, MS Office, Photoshop and illustrator., True, True, Adverse event reporting, Pharmacovigilance, Pharmaceutical labeling development, Manufacturing site quality system, Officer safety and occupational health, First aid, Methods of fire-fighting, industrial wastewater and the preservation of the environment and methods of analysis of industrial wastewater, Methods of disposal of hazardous waste
Timeline
Visiting Lecturer
Dubai Pharmacy College
01.2017 - 12.2018
Product Development Specialist (Formulation, Packaging and Analytical Development)
Medpharma, Bausch Health Pharmaceuticals
03.2011 - 09.2022
R&D formulator
Medizen Pharmaceutical Industries
04.2008 - 02.2011
Analyst in raw material lab
MEDIZEN Pharmaceutical Industries
11.2007 - 04.2008
Master of Science - Biotechnology
Alexandria University
11.2006 - 05.2008
R&D formulator
EASY BEAUTY Cosmetics Industries
07.2005 - 11.2007
Bachelor of Science -
AL-AZHAR, University
10.2001 - 05.2005
Product Development Person In Charge (Formulation, Packaging and Analytical Development)
Medpharma, Bausch Health Pharmaceuticals
9 2022 - Current